Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection (DENGUE-FACT)

Jose Ivan Rodriguez de Molina Serrano

Status: Not yet enrolling

Conditions: Dengue Fever; Dengue; Dengue Fever With Warning Signs

Study type: Observational

Funder types: Other

Identifiers

NCT07007585

CMX0003

Details and patient eligibility

About

This 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. It also seeks to analyze real-world transfusion practices and their outcomes. The study will be conducted in a second-level hospital in northern Mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.

Full description

This study will prospectively follow patients over 3 years to determine the relationship between clinical/laboratory variables and outcomes such as hospitalization and transfusion need. It seeks to improve understanding of real-world decision-making in transfusions for dengue-related thrombocytopenia and refine current hospitalization criteria based on locally observed predictors.

Patients will be enrolled consecutively at emergency departments or outpatient clinics with confirmed dengue infection. Clinical data (fever duration, bleeding signs, vomiting, abdominal pain, platelet count, hematocrit) and transfusion records will be collected and analyzed to identify independent predictors using multivariate logistic regression.

Enrollment: 100 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥5 years
• Laboratory-confirmed dengue infection (NS1, IgM, or PCR)
• First contact at emergency or outpatient services
• Informed consent signed by the patient or legal guardian

Exclusion criteria

• Co-infection with other arboviruses or COVID-19
• Pre-existing hematologic or oncologic disease
• Refusal to sign informed consent

Trial design

100 participants in 1 patient group

Inpatient Confirmed Dengue Cohort

Description:

This cohort includes patients aged 5 years and older with laboratory-confirmed dengue virus infection (via NS1 antigen, IgM serology, or PCR) who present to the emergency department or outpatient clinic at Clínica México. Patients are prospectively followed from initial presentation through resolution of illness or hospital discharge. No interventions are administered as part of the study; standard clinical care is provided. Data collection focuses on identifying clinical and laboratory predictors of hospitalization and transfusion, including platelet count, hematocrit changes, bleeding signs, and warning symptoms. Transfusion decisions are made independently by the attending physicians, and their rationale is recorded for analysis.